Journal of Pathology, Communicable Diseases and Preventive Medicines

Authors: Priya Nair, Vikram Desai

ABSTRACT: Pharmacovigilance (PV) plays a critical role in ensuring drug safety by monitoring adverse drug reactions (ADRs) and assessing therapeutic outcomes. Ethical considerations in PV studies are essential to protect patient rights, ensure data integrity, and maintain public trust in healthcare systems. This paper explores the ethical principles guiding PV, including informed consent, confidentiality, transparency, and equitable access to information. Challenges such as reporting bias, conflict of interest, and balancing patient confidentiality with public health obligations are discussed. Tables illustrate ethical frameworks, key PV responsibilities, and strategies to address ethical dilemmas. The paper emphasizes the integration of ethical guidelines, regulatory compliance, and continuous education to promote responsible pharmacovigilance practices.

KEYWORDS: Pharmacovigilance, Ethics, Adverse Drug Reactions, Informed Consent, Confidentiality, Patient Safety, Regulatory Compliance.